Revised: March 2010
(ATCVet code amended)
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
MS222 100% w/w Powder for Solution for Fish Treatment
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Substance
Qualitative composition
Tricaine Methane Sulphonate
Quantitative composition
100%
Excipients
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for fish treatment.
White to off white powder.
4.
CLINICAL PARTICULARS
4.1
Target species
1) Ornamental fish, or their development stages, and
2) Breeding and juvenile stages of fish.
4.2
Indications for use, specifying the target species
These include transportation, weighing, tagging, clipping, stripping of breed
stock, blood-sampling and surgical procedures.
4.3
Contraindications
The product should not be used in the following tropical fish species:
Apistogramma ramirezi, Balantocheilus melanopterus, Etroplus surrantensis,
Melanotaenia macculochi, Monodactylus argenteus, Phenacogrammus
interrupts and Scalopagus argus.
4.4
Special warnings for each target species
The product should not be used in the following tropical fish species:
Apistogramma ramirezi, Balantocheilus melanopterus, Etroplus surrantensis,
Melanotaenia macculochi, Monodactylus argenteus, Phenacogrammus
interruptus and Scalopagus argus.
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Revised: March 2010
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4.5
Special precautions for use
i.
Special precautions for use in animals
Do not exceed the dose recommended for each category of fish.
Brood stock anaesthetised for stripping should be immersed in
unmedicated water immediately before collection of eggs or milt
to avoid significant direct contact of either with the product.
As MS222 anaesthetic solutions are slightly acidic, the use of a
phosphate or imidazol buffer has been proposed to reduce
stress.
ii
Special precautions for the person administering the veterinary
medicinal product to animals.
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If you know you are hypersensitive (allergic) to anaesthetics such
as Tricaine mesilate (Tricaine methane sulphonate), do not
handle the product.
Do not create dust when handling the powder or preparing the
anaesthetic solution. In case of accidental inhalation of dust,
move to fresh air and if breathing is affected, seek medical
advice immediately and show the doctor the product label. In
situations where dust is created when handling the powder, wear
a disposable half mask respirator conforming to European
Standard EN 149 or a non-disposable respirator to European
Standard EN 140 with a filter to EN 143.
Wear impermeable rubber gloves when handling the product or
solution.
Avoid contact with skin and eyes in case of accidental contact
immediately wash the affected area with plenty of clean running
water. If irritation persists, seek medical advice.
Do not eat, drink or smoke whilst handling this product.
Wash hands after use.
iii.
4.6
Other precautions
None
Adverse reactions (frequency and seriousness)
None Known.
4.7
Use during pregnancy, lactation or lay
Not applicable.
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Revised: March 2010
(ATCVet code amended)
4.8
Interaction with other medicinal product s and other forms of interaction
MS222 has been used successfully at lower concentrations in conjunction with
several other anaesthetics. No adverse interaction with other pharmaceuticals
has been established.
4.9
Amount(s) to be administered and administration route
An Aqueous solution of the product is used in an immersion bath for sedation,
immobilisation and anaesthesia of fish, both ornamental and those intended
for human consumption.
A number of factors influence the efficacy and safety of the product, including
concentration of the drug in water, duration of exposure, temperature, oxygen
and density of biomass. Because of these variable factors it is strongly
recommended that a test of the selected drug concentration and exposure
time is conducted with a small group of representative fish before large
numbers are medicated. The product should be dissolved in water of the
same composition and characteristics as that to which the fish are
accustomed. As the product has good aqueous solubility, it may be added
directly to the container. Effects on the fish should be monitored as the
product is gradually introduced.
Before anaesthesia, or prolonged sedation, fish should be fasted for 12 to 24
hours. During treatment they should be stocked at a density not exceeding
80g/litre. To minimise damage and loss when medicated for long periods for
transport etc. The level of sedation should allow fish to maintain their
equilibrium and swimming position. Aeration should be provided unless
sedation, or anaesthesia, is of short duration. In anaesthesia loss of reflexes
takes place in one to fifteen minutes after immersion depending upon
concentration employed. Narcotised fish should be removed from medicated
water and returned to their normal environment as soon as possible, when
recover will take between one and thirty minutes.
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Revised: March 2010
(ATCVet code amended)
The following examples of dose rates and exposure times are based on
laboratory and field experience:MS222
Concentration
Immersion
Mg/litre of
time (mins)
water
Trout species (717ºC)
Sedation
10-30
Up to 480
Anaesthesia
Light
30-80
Up to 30
Deeper
80-180
Up to 10
Salmon species
Sedation
7-30
Up to 240
Anaesthesia
Light
30-80
Up to 10
Deeper
80-100
Up to 5
Bass species
Sedation
8-30
Up to 480
Anaesthesia
Light
30-70
Up to 20
Deeper
70-100
Up to 4
Carp species
Sedation
20-30
Up to 1440
Anaesthesia
30-200
Up to 8
Fresh water tropical fish
Sedation
30-50
Up to 1440
4.10
Overdose (symptoms, emergency procedures, antidotes), if necessary
Remove fish immediately to aerated water of the same composition and
temperature that is free from anaesthetic. Overdose or prolonged exposure to
the product may cause respiratory failure and death.
4.11
Withdrawal period(s)
Fish must not be slaughtered for human consumption during treatment. Fish
can only be harvested from human consumption 70 degree days after the last
treatment.
5.
PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group:
Anaesthetics, anaesthetics general, ethers
ATC Vet Code: QN01A
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Revised: March 2010
(ATCVet code amended)
5.1
Pharmacodynamic properties
Tricaine methane sulphonate has properties slightly different from, but similar
to, both ester and amide anaesthetics, acting as a general anaesthetic or
narcotic. It is more water-soluble than Benzocaine, lending it to fish
application. Fish are normally immersed in solutions and both absorption and
excretion occur through the gill epithelium.
It is soluble in lipids, which probably accounts for its rapid diffusion across gills
in both directions, with rapid anaesthesia and rapid recovery. The drug is
distributed throughout the body. The drug causes reduced blood flow through
the gills and reduced oxygen consumption. The rate at which narcosis is
induced depends upon the concentration of the product in water and also upon
the water temperature. At higher temperatures onset or narcosis is more
rapid; however the safety margin is less. Immersion of fish in unmedicated
water reverses narcotic effects.
5.2
Pharmacokinetic properties
Excretion occurs mainly across the gill epithelium. Non-polar ethyl metaaminobenzoate and its N-acetyl derivative are both excreted across the gills,
whereas the polar meta-aminobenzoic acid and its N-acetyl derivative are
excreted via the kidneys. All species tested appear to produce an acetylated
derivative, to the extent normally of less than 20% of the original anaesthetic.
The hydrolysis to produce the free acid also varies with species, so the kidney
excretion varies with species. However, the effectiveness varies less between
species owing to the free movement of the drug across the gills.
The concentration in salmonid muscle, whilst the fish is under anaesthetic,
ranges from 9.4mg to 72.0 mg/kg. The half life of the anaesthetic in muscle on
withdrawal is approximately 70 minutes. Thus 24 hours gives 20 half lives.
The highest concentrations found in salmonid muscle after 24 hours have
been 2.6 to 3.2 mg/kg (the oral LD in a 30kg dog is 30,000 x 4mg of the
anaesthetic). The withdrawal period set is 70 degree days.
5.3
Environmental properties
None known.
6.
PHARMACEUTICAL PARTICULARS
6.1
List of excipients
None.
6.2
Incompatibilities
No major incompatibilities have been demonstrated for any species in the
range of species for which the product is recommended.
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Revised: March 2010
(ATCVet code amended)
6.3
Shelf life
Shelf life of the veterinary medicinal product as packaged fro sale: 5 years.
Shelf life after dilution or reconstitution according to directions: 12 hours.
6.4
Special precautions for storage
Do not store above 25ºC.
Protect from direct sunlight.
Store in the original container.
Store in a dry place.
Keep the container tightly closed in order to protect from moisture.
Re-seal open packets immediately after use to exclude moisture.
Protect solution from direct sunlight.
6.5
Nature and contents of container
High Density Polyethylene (HDPE) tamper resistant tubs closed with and
integral, tamper evident, low density polyethylene cap (snap on) containing
either 25g, 100g, 250g or 1000g.
Not all pack sizes may be marketed.
6.6
Special precautions for the disposal of unused veterinary medicinal
product or waste materials derived from the us of such products, if
appropriate
Any unused veterinary medicinal product or waste materials derived from such
veterinary medicinal products should be disposed of in accordance with local
requirements.
7.
MARKETING AUTHORISATION HOLDER
Pharmaq Limited
Unit 15
Sandleheath Industrial Estate
Fordingbridge
Hants SP6 1PA
8.
MARKETING AUTHORISATION NUMBER(S)
Vm 11003/4013
9.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
01 September 1992
10.
DATE OF REVISION OF THE TEXT
March 2010 (ATCVet code amended)
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